JP4414461B2 - Device for impregnation of porous bone substitute material - Google Patents

Device for impregnation of porous bone substitute material Download PDF

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JP4414461B2
JP4414461B2 JP2007513641A JP2007513641A JP4414461B2 JP 4414461 B2 JP4414461 B2 JP 4414461B2 JP 2007513641 A JP2007513641 A JP 2007513641A JP 2007513641 A JP2007513641 A JP 2007513641A JP 4414461 B2 JP4414461 B2 JP 4414461B2
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container
central axis
cavity
lid
mainly
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JP2008501377A (en
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ホーゲル、フラヴィオ
ストール、テリー
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Synthes GmbH
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Stratec Medical AG
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A device for the impregnation of a porous bone replacement material with an impregnation agent includes a container with a central axis and a cavity with a lid. The container has two sealable openings and elastic means. The elastic means are arranged in the cavity allowing a clamping force to be exerted on a bone replacement material inserted in the cavity. A single size container is sufficient for housing variously sized implants, where the implant placed in the cavity of the container is held, centered and protected against damage or breakage, for example, by shaking back and forth or during transportation of the container.

Description

本発明は特許請求項1の上位概念に基づく多孔性骨代用材料の含浸のための装置に関する。   The invention relates to a device for impregnation of porous bone substitute material according to the superordinate concept of claim 1.

多孔性の、生体適合性骨代用体の含浸のための装置は、US 6,049,026 MUSCHLER(特許文献1)から周知である。この周知の装置は、骨代用体の収容のためのチャンバー、ならびに前記チャンバーの上に、含浸剤の貯蔵のための第一の容器、および前記チャンバーの下に、チャンバーを通じて骨代用体と共に流れる含浸剤の収容のための第二の容器を含む。第一の容器とチャンバーの間に配置された第一の弁を開放することによって含浸剤が、骨代用体と共にチャンバーに流れ込む。チャンバーが満たされて、チャンバーと前記第二の容器の間に配置された第二の弁を開放することによって、含浸剤が骨代用体の下に配置された膜を通じて第二の容器に流れ込むことができる。この周知の装置の欠点は、チャンバー内の骨代用体が挟着され得ないことによって、骨代用体およびインプラントが、例えば輸送の際に、揺すられることによって損傷または破損することが起こりえることにある。
US 6,049,026MUSCHLER
A device for impregnation of a porous, biocompatible bone substitute is well known from US 6,049,026 MUSCHLER. This known device comprises a chamber for containing a bone substitute, a first container for storing an impregnant on the chamber, and an impregnation that flows with the bone substitute through the chamber below the chamber. A second container for containing the agent is included. By opening the first valve located between the first container and the chamber, the impregnating agent flows into the chamber along with the bone substitute. The chamber is filled and the impregnant flows into the second container through the membrane placed under the bone substitute by opening a second valve located between the chamber and the second container Can do. The disadvantage of this known device is that the bone substitute and the implant in the chamber cannot be clamped, so that the bone substitute and the implant can be damaged or broken by shaking, for example during transport. is there.
US 6,049,026 MUSCHLER

本発明はこれに是正を講じるものである。本発明は、多孔性骨代用材料の含浸のための装置であって、インプラント、すなわち骨代用材料から成る物体が空洞内で、輸送の際の振動による損傷から保護されている装置を造る課題と基礎としている。
本発明は、請求項1の特徴を有し、多孔性骨代用材料の含浸のための装置を以って、与えられた課題を解決する。発明による装置で達成される実利は、本質的に以下にある。発明による装置によって:
−様々な大きさのインプラントを収容できるために、容器が一つで十分であること、
−容器の空洞に封入されたインプラントが維持され、および中心合わせされ、例えば振動または容器の輸送の際の損傷または破損から保護されること。
The present invention corrects this. The object of the present invention is to create a device for impregnation of a porous bone substitute material, in which an implant, i.e. an object made of bone substitute material, is protected from vibration damage during transport in a cavity. It is based.
The invention has the features of claim 1 and solves the given problem with a device for impregnation of a porous bone substitute material. The benefits achieved with the device according to the invention are essentially as follows. By the device according to the invention:
-One container is sufficient to accommodate implants of various sizes;
The implant enclosed in the cavity of the container is maintained and centered and protected from damage or breakage, for example during vibration or transport of the container.

弾性手段は、主として蛇腹または「ばね」の形態で形成されることがある。弾性手段は複数の、中心軸に関して、へリックスまたはスパイラル形状に配置された弾性受骨を含み、中心軸に対して同心に配置されたばね素子を含むことがある。そのような受骨を備えた前記ばね素子の形態は、含浸剤のために大きな通過開口部を設けることを可能にし、ばね素子通過の際の抵抗がより少なくなる。その他の実利は、保持力がインプラント上で一様であることと、その上さらに、インプラントが中心合わせされることである。受骨は、蓋の方向に向き、穿孔を有し、中心軸に同心に配置され、中心軸に直角に測った直径dが、中心軸に直角に測った空洞の直径Dの0.001%と99.999%の間、主として0.1%と99.9%の間にある中心板に結合する上端部を有すことがある。直径dは直径D1%と99%の間、主として5%と95%の間にある。典型的には、直径dは直径Dの10%と90%の間、主として20%と80%の間にある。有利なことには、直径dは直径Dの25%と75%の間、主として30%と40%の間にある。空洞の直径に対して相対的に小さな中心板直径は、含浸剤にさらされないインプラントの表面部分を小さくする。その他の実利は、保持力がインプラント上で一様であることと、さらにその上、インプラントが中心合わせされることである。   The elastic means may be formed primarily in the form of bellows or “springs”. The elastic means may include a plurality of elastic bones arranged in a helix or spiral shape with respect to the central axis, and may include spring elements arranged concentrically with respect to the central axis. The form of the spring element with such ribs makes it possible to provide a large passage opening for the impregnating agent and less resistance when passing through the spring element. Another advantage is that the holding force is uniform on the implant and furthermore, the implant is centered. The ribs are oriented in the direction of the lid, have perforations, are arranged concentrically with the central axis, and the diameter d measured perpendicular to the central axis is 0.001% of the diameter D of the cavity measured perpendicular to the central axis And 99.999%, mainly between 0.1% and 99.9%, may have an upper end that joins the center plate. The diameter d is between the diameters D1% and 99%, mainly between 5% and 95%. Typically, the diameter d is between 10% and 90% of the diameter D, mainly between 20% and 80%. Advantageously, the diameter d is between 25% and 75% of the diameter D, mainly between 30% and 40%. A central plate diameter that is relatively small relative to the cavity diameter reduces the surface area of the implant that is not exposed to the impregnating agent. Another advantage is that the holding force is uniform on the implant and furthermore the implant is centered.

その他の実施形態において、受骨は、ばね素子の外リングに結合する下端部を有す。外リングは空洞に遊びなく軸着されることができる。結果的には、弾性手段は蓋の螺嵌後に、インプラントに対して加圧するばね素子によって、および空洞に遊びがないために固定されている。その他の実利は、封止の形状が軸からの振れ落ちを許さないこと、および、下外リングの死容積が少なくなることで環流に際し、血液が少なくて済むことにある。
その他の実施形態においては、圧力容器と蓋の間に封止が配置されている。これによって容器は真空においても気密が保たれる。
その他の実施形態においては、ばね素子と封止は一部品から成るように形成されている。それによって装置の単純な結合が実現され、前記封止が損なわれることがない。
その他の実施形態においては、中心軸に平行に測った空洞の高さHは、中心軸に平行に測った外リングと封止の高さによって定義されている。それによって、例えば様々な封止または様々なばね素子を空洞の高さの定義に使用することができる。その他の実利は、生産費用と梱包費用の削減にある。複数の様々な大きさのインプラントに対して一つの容器を使用すればよいからだ。もう一つの選択肢は、中心軸に平行に測った高さが、様々な高さの内部部品によって、主として蓋によって定義されている。
In other embodiments, the bone has a lower end that couples to the outer ring of the spring element. The outer ring can be pivoted into the cavity without play. As a result, the elastic means is fixed by a spring element that presses against the implant after screwing of the lid and in order to avoid play in the cavity. Other practical advantages are that the shape of the seal does not allow the shaft to fall off, and that the dead volume of the lower outer ring is reduced, so that less blood is required for circulation.
In other embodiments, a seal is disposed between the pressure vessel and the lid. This keeps the container airtight even in vacuum.
In other embodiments, the spring element and the seal are formed of a single piece. Thereby a simple coupling of the devices is realized and the sealing is not impaired.
In other embodiments, the height H of the cavity measured parallel to the central axis is defined by the height of the outer ring and the seal measured parallel to the central axis. Thereby, for example, various seals or various spring elements can be used to define the height of the cavity. Another benefit is in reducing production and packaging costs. This is because a single container may be used for a plurality of implants of various sizes. Another option is that the height, measured parallel to the central axis, is defined mainly by the lid by means of internal components of various heights.

その以外の実施形態においては、弾性手段は(中心軸に平行に測って)無負荷状態で高さhを有し、および、ある分量Δhだけ軸方向に圧縮可能であり、割合Δh/hが0.001%と99.999%の間、主として0.01%と99.99%の間にある。典型的には、前記割合Δh/hは0.1%と99.9%の間にあり、主として1%と99%の値にある。有利なことには、割合Δh/hは5%と95%の間、主として10%と90%の間にある。そのため弾性手段は、相当量、圧縮可能であり、様々な大きさのインプラントで装備できる。
その他の実施形態においては、容器は円筒状に形成されていて、そして空洞に同心に配置された雌ねじを有す。蓋は前記雌ねじを補完する雄ねじを含む。
有利なことには、容器は全容積vが空洞(13)の容積Vより少ない多孔性骨代用材料を含む。前記骨代用材料はブロックの形態、主として立方体の、円筒の、中空円筒の、円盤の、くさびの、円錐の、円錐台あるいは球の形態である。骨代用材料は、少なくともインプラントの表面に連通するようにインプラントに収容されている。
In other embodiments, the elastic means has a height h in an unloaded condition (measured parallel to the central axis) and is compressible in the axial direction by a certain amount Δh, with a ratio Δh / h of It is between 0.001% and 99.999%, mainly between 0.01% and 99.99%. Typically, the ratio Δh / h is between 0.1% and 99.9%, mainly at values of 1% and 99%. Advantageously, the ratio Δh / h is between 5% and 95%, mainly between 10% and 90%. Therefore, the elastic means is compressible to a considerable extent and can be equipped with implants of various sizes.
In other embodiments, the container is cylindrically shaped and has an internal thread disposed concentrically in the cavity. The lid includes a male screw that complements the female screw.
Advantageously, the container comprises a porous bone substitute material whose total volume v is less than the volume V of the cavity (13). The bone substitute material is in the form of blocks, primarily cubic, cylindrical, hollow cylindrical, disk, wedge, conical, truncated cone or sphere. The bone substitute material is accommodated in the implant so as to communicate with at least the surface of the implant.

インプラントが、以下の材料グループのいずれかの一グループから選択され得る:
A)金属、および
B)樹脂、および
C)非金属、主としてガラス、および
D)様々な密度の磁器、および
E)複合磁器
またはAからEのいずれか一項。
弾性手段は中心軸に対して対称または非対称のいずれかに配置されることができる。インプラントの仕様と形状によって、インプラントがより堅固に固定されるように対称または非対称構造で提供される。
容器の底は、中心または非中心が穿設された、両開口部を形成する接続子を備えることができる。蓋の覆板の外側にも中心または非中心が穿設された、両開口部の一つを形成する接続子が配置することができる。
骨代用材料は、ブロックの形態、主として立方体の、円筒の、中空円筒の、円盤の、くさびの、円錐の、円錐台あるいは球の形態である。含浸剤は骨誘導性物質および骨形成性物質またはいずれか一方、体細胞、骨髄または骨髄構成成分、血液または血液成分またはそれらの組み合わせを含む。
The implant may be selected from any one of the following material groups:
A) Metal, and B) Resin, and C) Nonmetal, primarily glass, and D) Porcelain of various densities, and E) Composite porcelain or any one of A to E.
The elastic means can be arranged either symmetrically or asymmetrically with respect to the central axis. Depending on the specification and shape of the implant, it is provided in a symmetric or asymmetric structure so that the implant is more firmly fixed.
The bottom of the container can be provided with a connector forming both openings, drilled in the center or non-center. A connector that forms one of the two openings, the center or non-center of which is formed on the outside of the cover cover plate, can be disposed.
The bone substitute material is in the form of blocks, mainly cubic, cylindrical, hollow cylindrical, disc, wedge, conical, truncated cone or sphere. The impregnating agent comprises osteoinductive and / or osteogenic substances, somatic cells, bone marrow or bone marrow components, blood or blood components or combinations thereof.

発明および発明の発展形を、部分的に図解により、実施例を表示しながら以下により詳細に説明する。
(図面の簡単な説明)
図1は、発明による装置の実施形態の断面図である。
図2は、発明による装置の図1に表示された実施形態の平面図である。
図3は、発明による装置の図1と図2に示した実施形態の弾性手段部品の見取り図である。
図4は、図3に表示した弾性手段部品の断面図である。
図5は、図1に円で印した弾性手段部品の正面図である。
図6は、図5に示した接続子の平面図である。
図7は、発明による装置および注射器の実施形態の透視図である。
The invention and further developments of the invention are explained in more detail below, partly by illustration and with examples.
(Brief description of the drawings)
FIG. 1 is a cross-sectional view of an embodiment of an apparatus according to the invention.
FIG. 2 is a plan view of the embodiment shown in FIG. 1 of the device according to the invention.
FIG. 3 is a sketch of the elastic means part of the embodiment shown in FIGS. 1 and 2 of the device according to the invention.
4 is a cross-sectional view of the elastic means component shown in FIG.
FIG. 5 is a front view of the elastic means component marked with a circle in FIG.
FIG. 6 is a plan view of the connector shown in FIG.
FIG. 7 is a perspective view of an embodiment of the device and syringe according to the invention.

図1には、中心軸10に同心の、またその上に同心の蓋8を持つ円柱容器6を含む発明による装置の実施形態を示す。容器6は、その空洞13内に、前記中心軸10に同心の雌ねじ7を有すため、外郭側面に前記雌ねじ7を補完する雄ねじ9を有する前記蓋8は、前記容器6に緩嵌可能である。雌ねじ7は、容器6内の前記空洞13の全軸長に亘って延びている(容器6の半分までの多段ねじを使用する選択肢もあろう)。蓋8の外郭側面の前記雄ねじ9は、蓋8の全軸長に亘って延びている。空洞13には、特に軸方向に弾性のあるばね素子30およびそれと一体の封止31を有す弾性手段19が配置されている。
中空円筒形の封止31は中心軸10に平行に、前記ばね素子30に属する外リング37の上端部38と蓋8の下端部の間に延びる。前記外リング37の下端部39は容器6の底16上に立ち、その一方で外リング37の上端部38は封止31の下端部と接続されている。外リング37は容器6の外径内に、内径に合致するように形成されているため、弾性手段19は中心軸10に直角の変位に対して保護されている。
FIG. 1 shows an embodiment of the device according to the invention comprising a cylindrical container 6 which is concentric with a central axis 10 and has a concentric lid 8 thereon. Since the container 6 has a female screw 7 concentric with the central shaft 10 in the cavity 13, the lid 8 having a male screw 9 that complements the female screw 7 on the outer side surface can be loosely fitted to the container 6. is there. The female thread 7 extends over the entire axial length of the cavity 13 in the container 6 (there may be the option to use multistage screws up to half of the container 6). The male screw 9 on the outer side surface of the lid 8 extends over the entire axial length of the lid 8. In the cavity 13, an elastic means 19 having a spring element 30 which is elastic in the axial direction and a seal 31 integrated therewith is arranged.
A hollow cylindrical seal 31 extends parallel to the central axis 10 between the upper end 38 of the outer ring 37 belonging to the spring element 30 and the lower end of the lid 8. The lower end 39 of the outer ring 37 stands on the bottom 16 of the container 6, while the upper end 38 of the outer ring 37 is connected to the lower end of the seal 31. Since the outer ring 37 is formed within the outer diameter of the container 6 so as to match the inner diameter, the elastic means 19 is protected against displacement perpendicular to the central axis 10.

蓋8は、蓋8の下端部17が封止31の上端部に達するまで空洞13に螺嵌可能である。雌ねじ7および雄ねじ9は、多段ねじとして形成されている。容器6の底16は、中心軸10に同心に中心が穿設された接続子21が配置された中心軸10に同心の窪み20を有す。接続子21の中心孔24は開口部4を形成している。それに類似して、蓋8の覆板18外部には、第二の中心軸10に同心に穿設された接続子25が配置されている。接続子21および25は同等に形成されている(接続子21および25が別様に形成される選択肢もあろう)。
容器6の空洞13に封入された骨代用材料片1は蓋8を容器内に螺嵌する際に、ばね素子30の上端部を加圧するため、前記ばね素子30は軸方向に、ある分量Δhだけ圧縮される。ばね素子30の弾性により、骨代用材料1から成る物体は、ばね素子30の上端部29と蓋8の覆板18に挟入される。
The lid 8 can be screwed into the cavity 13 until the lower end 17 of the lid 8 reaches the upper end of the seal 31. The female screw 7 and the male screw 9 are formed as multistage screws. The bottom 16 of the container 6 has a concentric recess 20 in the central shaft 10 on which a connector 21 concentrically drilled in the central shaft 10 is disposed. The central hole 24 of the connector 21 forms the opening 4. Similarly, a connector 25 drilled concentrically with the second central shaft 10 is disposed outside the cover plate 18 of the lid 8. The connectors 21 and 25 are formed equally (there may be an option that the connectors 21 and 25 are formed differently).
The bone substitute material piece 1 enclosed in the cavity 13 of the container 6 pressurizes the upper end of the spring element 30 when the lid 8 is screwed into the container, so that the spring element 30 is axially divided by a certain amount Δh. Only compressed. Due to the elasticity of the spring element 30, the object made of the bone substitute material 1 is sandwiched between the upper end portion 29 of the spring element 30 and the cover plate 18 of the lid 8.

図3および4に、弾性手段19の、外リング37および前記外リング37の上端部38に配置された円錐台形環節40を備えた実施形態を示す。前記円錐台形環節40は、その上端部42が、ばね素子30の上端部29において、中心軸に同心に配置され、穿孔44を有す中心板41に結合し、そして外リング37を備えた下端部43に結合する受骨34を含む。円錐台形環節40は、ばね素子30の上端部29に向かって小さくなるように形成されている。その際、受骨34は中心軸10周りにスパイラル状に走る。   3 and 4 show an embodiment of the elastic means 19 comprising an outer ring 37 and a frustoconical annulus 40 arranged at the upper end 38 of the outer ring 37. The frustoconical annulus 40 has an upper end 42 concentric with the central axis at the upper end 29 of the spring element 30, joined to a central plate 41 having a bore 44, and a lower end with an outer ring 37. A rib 34 coupled to the portion 43 is included. The frustoconical annular node 40 is formed so as to become smaller toward the upper end portion 29 of the spring element 30. At that time, the rib 34 runs spirally around the central axis 10.

図5および6には、ルアーロックオスコネクターとして同等に形成された結合素子21、25を示す。それぞれの結合素子21、25はその自由終端部に半径方向に突出したカム23を含み、それぞれ2つの相互に直径方向に対向する弦巻線28の環節によって形成されている。接続子21の開口部に補完ルアーロックメスコネクターとして形成された標準注射器15(図7)は、前記結合素子21、25の内のそれぞれを通じて螺嵌可能(ルアー結合)である。結合方法は、様々なアダプターが気密に結合できるように選択できる。
窪み20内の接続子21が容器6の底16上に突起しないような、接続子21の配置(図1)によって、容器6を倒すことなく底上に立たせることが実現する。蓋8の螺挿または螺脱を簡素化するために、蓋8の覆板18の外側に、2つの軸方向に出っ張った突起11および容器6の外郭表面に走る溝26が設けられている(図2)。
FIGS. 5 and 6 show coupling elements 21 and 25 that are equally formed as luer lock male connectors. Each coupling element 21, 25 comprises a radially projecting cam 23 at its free end, each formed by two mutually diametrically opposed chord winding 28 annulus. A standard syringe 15 (FIG. 7) formed as a complementary luer lock female connector in the opening of the connector 21 can be screwed (luer coupling) through each of the coupling elements 21 and 25. The coupling method can be selected so that various adapters can be hermetically coupled.
By arranging the connector 21 so that the connector 21 in the recess 20 does not protrude on the bottom 16 of the container 6 (FIG. 1), it is possible to stand the container 6 on the bottom without falling down. In order to simplify the screwing or screwing of the lid 8, two axially projecting projections 11 and a groove 26 running on the outer surface of the container 6 are provided outside the cover plate 18 of the lid 8 ( Figure 2).

図7は、空洞に閉じ込められた、骨代用材料1から成る物体を満たした容器6を示す。容器6は、注射器15と気密結合可能な、2つの開口部3、4を持つ。含浸剤5として前記注射器15は、その空洞内に骨誘導性物質および骨形成性物質またはいずれか一方、特に体細胞、骨髄または骨髄構成成分、血液または血液成分またはそれらの組み合わせを含む。ここに示した容器6は注射器15と共に以下のステップを含む発明による方法を実効する。
A)含浸剤5で満たされた注射器15は、容器6の両開口部4の内、主として下開口部に連結される。上開口部3は閉じない状態に残す。両開口部3、4は、ひとつの円錐状に穿設され、容器6と連接した結合素子21、25を備えたルアー開口部として形成されている(図5、図6)。含浸剤5が、そこでピストン12によって下開口部4を通じて容器6に注入されることによって、多孔性骨代用材料1から成るブロックは含浸剤5に囲まれ、その中で部分的、主として全体的に浸る。
B)そこで前記上開口部3を閉じる。
C)その後で注射器5のピストン12を再び引き戻すことによって容器6内部には負圧または真空が生じる。真空によって骨代用材料1の細孔内に存在する空気は膨張に至り、細孔から周囲の含浸剤5に出る。これは閉じた系に関するものなので、含浸剤5はピストン運動によって一部分だけ掃気される。これは容器6内にまだ空気が含まれている場合のみ可能である。含浸剤5の大多数においてはさらに、付着特性を示すことで、空気は骨代用材料1の表面に付着し、ピストン運動によっても吸収されない。
D)次のステップにおいて、注射器5のピストン12は再び、元の位置に押し戻されるため、容器6の真空は保存される。含浸剤5に囲まれた骨代用材料1のブロックはもちろん、その細孔に空気ではなく含浸剤5を吸収するため、骨代用材料1の含浸が起こる。注射器5によって実施可能な容器内の真空の排気/保存は、含浸率を上げるため何度も繰り返すことができる。含浸剤5は空気に比較して、その吸着と多孔性骨代用材料1の構造の毛細管効果によってむしろ内部に吸収される。
FIG. 7 shows a container 6 filled with an object made of bone substitute material 1 enclosed in a cavity. The container 6 has two openings 3 and 4 that can be hermetically coupled to the syringe 15. The syringe 15 as the impregnating agent 5 contains an osteoinductive substance and / or an osteogenic substance, particularly somatic cells, bone marrow or bone marrow components, blood or blood components or a combination thereof, in the cavity. The container 6 shown here implements the method according to the invention including the following steps together with the syringe 15.
A) The syringe 15 filled with the impregnating agent 5 is connected mainly to the lower opening of the two openings 4 of the container 6. The upper opening 3 is left unclosed. Both openings 3 and 4 are formed as a lure opening provided with coupling elements 21 and 25 connected to the container 6 by being drilled in one conical shape (FIGS. 5 and 6). The impregnating agent 5 is then injected by the piston 12 through the lower opening 4 into the container 6, so that the block of porous bone substitute material 1 is surrounded by the impregnating agent 5, in which partly, mainly entirely. Immerse.
B) The upper opening 3 is closed there.
C) Thereafter, a negative pressure or a vacuum is generated inside the container 6 by pulling back the piston 12 of the syringe 5 again. The air existing in the pores of the bone substitute material 1 is expanded by the vacuum, and exits from the pores to the surrounding impregnating agent 5. Since this relates to a closed system, the impregnating agent 5 is only partially scavenged by the piston movement. This is only possible if the container 6 still contains air. The majority of impregnating agents 5 also exhibit adhesion properties, so that air adheres to the surface of the bone substitute material 1 and is not absorbed by piston motion.
D) In the next step, the piston 12 of the syringe 5 is again pushed back to its original position, so that the vacuum in the container 6 is preserved. The block of the bone substitute material 1 surrounded by the impregnating agent 5 absorbs the impregnating agent 5 instead of air into the pores, so that the bone substitute material 1 is impregnated. The evacuation / storage in the container, which can be performed by the syringe 5, can be repeated many times to increase the impregnation rate. Compared with air, the impregnating agent 5 is rather absorbed inside by its adsorption and the capillary effect of the structure of the porous bone substitute material 1.

この方法の他の実施形態は、第一の、含浸剤5に満たされた注射器15が2つの開口部3、4のひとつに連結されて後、第二の満たされていない注射器(図示されていない)が他の開口部3、4に連結され、ピストンを引き戻すことによって、容器6の空洞は排気され、そして同時に生じた負圧によって含浸剤5が注射器15の空洞から容器6の空洞に吸い込まれることによって成り立つ。骨代用材料1の細孔の中の空気は細孔から排出する。それに続き、第二の注射器のピストンを押し込むことによって、空気は再び容器6に供給されるため、容器6の空洞の真空は再び保たれ、そして含浸剤5は骨代用材料1の細孔に侵入する。
この方法のさらにその他の実施形態は、第二の注射器(図示されていない)が真空の拡大に使用されることによって成り立つ。前記第二の注射器は(含浸剤5に満たされていないため)第一の、含浸剤5に満たされた注射器15に比較して著しく大きな真空を示す。
Another embodiment of this method is that after a syringe 15 filled with the first impregnating agent 5 is connected to one of the two openings 3, 4, a second unfilled syringe (not shown) is shown. Is not connected) to the other openings 3 and 4 and by pulling back the piston, the cavity of the container 6 is evacuated and simultaneously the negative pressure that is generated causes the impregnating agent 5 to be sucked into the cavity of the container 6 from the cavity of the syringe 15 It is realized by being. Air in the pores of the bone substitute material 1 is discharged from the pores. Subsequently, by pushing the piston of the second syringe, air is again supplied to the container 6 so that the vacuum in the cavity of the container 6 is maintained again and the impregnating agent 5 penetrates into the pores of the bone substitute material 1 To do.
Yet another embodiment of this method consists in that a second syringe (not shown) is used for expanding the vacuum. Said second syringe (because it is not filled with the impregnating agent 5) exhibits a significantly larger vacuum compared to the first syringe 15 filled with the impregnating agent 5.

発明による装置の実施形態の断面図である。1 is a sectional view of an embodiment of a device according to the invention. 発明による装置の図1に表示された実施形態の平面図である。Fig. 2 is a plan view of the embodiment shown in Fig. 1 of the device according to the invention. 発明による装置の図1と図2に示した実施形態の弾性手段部品の見取り図である。FIG. 3 is a sketch of the elastic means component of the embodiment shown in FIGS. 1 and 2 of the device according to the invention. 図3に表示した弾性手段部品の断面図である。It is sectional drawing of the elastic means component displayed on FIG. 図5は、図1に円で印した弾性手段部品の正面図である。FIG. 5 is a front view of the elastic means component marked with a circle in FIG. 図5に示した接続子の平面図である。It is a top view of the connector shown in FIG. 発明による装置および注射器の実施形態の透視図である。1 is a perspective view of an embodiment of a device and syringe according to the invention. FIG.

符号の説明Explanation of symbols

1 多孔性骨代用材料 2 容器 3、4 開口部 5 含浸剤 6 容器
8 蓋 10 中心軸 13 空洞 14 装置 19 弾性手段
DESCRIPTION OF SYMBOLS 1 Porous bone substitute material 2 Container 3, 4 Opening part 5 Impregnating agent 6 Container 8 Lid 10 Center axis 13 Cavity 14 Apparatus 19 Elastic means

Claims (27)

多孔性骨代用材料(1)の含浸のための、含浸剤(5)を有す装置(14)であって、
A)中心軸(10)および空洞(13)を有し、蓋(8)を持つ容器(6)を備え、その際
B)容器(2)が、二つの閉鎖可能な開口部(3、4)を有し、
C)前記容器(6)が、前記空洞(13)に配置された、弾性手段(19)を含み、それにより、空洞(13)に封入された前記骨代用材料(1)に挟着力を及ぼすことができ
D)前記容器(6)が、真空になることができるような方法で構成され、
E)前記容器(6)が、その空洞(13)内に、外郭側面に雌ねじ(7)を補完する雄ねじ(9)を有する前記蓋(8)が前記容器(6)に緩嵌可能であるように前記中心軸(10)に同心の雌ねじ(7)を有する
ことを特徴とする装置。
A device (14) having an impregnating agent (5) for impregnation of a porous bone substitute material (1),
A) A container (6) having a central axis (10) and a cavity (13) and having a lid (8), wherein B) the container (2) has two closable openings (3, 4). )
C) The container (6) includes elastic means (19) disposed in the cavity (13), thereby exerting a clamping force on the bone substitute material (1) enclosed in the cavity (13). it can,
D) The container (6) is constructed in such a way that it can be evacuated,
E) In the cavity (13) of the container (6), the lid (8) having a male screw (9) that complements the female screw (7) on the outer side surface can be loosely fitted to the container (6). An apparatus having a concentric female screw (7) on the central shaft (10) as described above .
前記弾性手段(19)が、蛇腹または「ばね」の形態で形成されていることを特徴とする請求項1に記載の装置(14)。  Device (14) according to claim 1, characterized in that said elastic means (19) are formed in the form of bellows or "springs". 弾性手段(19)が、前記中心軸(10)に関して、複数のヘリックスまたはスパイラル形状に配置された弾性受骨(34)を含み、中心軸(10)に同心に配置されたばね素子(30)を含むことを特徴とする請求項1に記載の装置(14)。  The elastic means (19) includes a plurality of helical bones (34) arranged in a helix or spiral shape with respect to the central axis (10), and a spring element (30) arranged concentrically on the central axis (10). Apparatus (14) according to claim 1, characterized in that it comprises. 前記受骨(34)が、前記蓋(8)の方向に向き、穿孔(44)を有し、中心軸(10)に同心に配置され、中心軸(10)に直角に測った直径dが、中心軸(10)に直角の空洞(13)の直径Dの0.001%と99.999%の間、主として0.1%と99.9%の間にある中心板(41)に結合する上端部(42)を持つことを特徴とする請求項3に記載の装置(14)。  The bone (34) is oriented in the direction of the lid (8), has a perforation (44), is arranged concentrically with the central axis (10) and has a diameter d measured perpendicular to the central axis (10). To the central plate (41) between 0.001% and 99.999%, mainly between 0.1% and 99.9% of the diameter D of the cavity (13) perpendicular to the central axis (10) Device (14) according to claim 3, characterized in that it has an upper end (42). 前記直径dが、前記直径Dの1%と99%の間、主として5%と95%の間にあることを特徴とする請求項4に記載の装置(14)。  Device (14) according to claim 4, characterized in that the diameter d is between 1% and 99% of the diameter D, mainly between 5% and 95%. 直径dが、直径Dの10%と90%の間、主として20%と80%の間にあることを特徴とする請求項5に記載の装置(14)。  Device (14) according to claim 5, characterized in that the diameter d is between 10% and 90% of the diameter D, mainly between 20% and 80%. 直径dが、直径Dの25%と75%の間、主として30%と40%の間にあることを特徴とする請求項6に記載の装置(14)。  7. Device (14) according to claim 6, characterized in that the diameter d is between 25% and 75% of the diameter D, mainly between 30% and 40%. 受骨(34)が、ばね素子(30)の外リング(37)に結合する下端部(43)を有することを特徴とする請求項3から7のいずれか一項に記載の装置(14)。  Device (14) according to any one of claims 3 to 7, characterized in that the bone receiving (34) has a lower end (43) which is coupled to the outer ring (37) of the spring element (30). . 外リング(37)が、中心軸(10)に直角に空洞(13)に遊びなく軸着されていることを特徴とする請求項8に記載の装置(14)。  9. Device (14) according to claim 8, characterized in that the outer ring (37) is axially mounted in the cavity (13) at right angles to the central axis (10) without play. 容器(6)と蓋(8)の間に封止(31)が配置されていることを特徴とする請求項1から9のいずれか一項に記載の装置(14)。  10. Device (14) according to any one of the preceding claims, characterized in that a seal (31) is arranged between the container (6) and the lid (8). ばね素子(30)および前記封止(31)が一部品から成ることを特徴とする請求項10に記載の装置(14)。  Device (14) according to claim 10, characterized in that the spring element (30) and the seal (31) are in one piece. 中心軸(10)に平行に測った空洞(13)の高さHが、中心軸(10)に平行に測った外リング(37)および封止(31)の高さによって定義されていることを特徴とする請求項10または11に記載の装置(14)。  The height H of the cavity (13) measured parallel to the central axis (10) is defined by the height of the outer ring (37) and the seal (31) measured parallel to the central axis (10). Device (14) according to claim 10 or 11, characterized in that 中心軸(10)に平行に測った高さが、様々な高さの内部部品によって、主として蓋(8)によって定義されていることを特徴とする請求項10または11に記載の装置(14)。  12. Device (14) according to claim 10 or 11, characterized in that the height measured parallel to the central axis (10) is defined mainly by the lid (8) by internal components of various heights. . 弾性手段(19)が、無負荷状態で中心軸(10)に平行に測った高さhを有し、および、ある分量Δhだけ軸方向に圧縮可能であり、割合Δh:hが0.001%と99.999%の間、主として0.01%と99.99%の間にあることを特徴とする請求項1から13のいずれか一項に記載の装置(14)。  The elastic means (19) has a height h measured parallel to the central axis (10) in an unloaded state and is compressible in the axial direction by a certain amount Δh, the ratio Δh: h being 0.001. 14. Device (14) according to any one of claims 1 to 13, characterized in that it is between% and 99.999%, mainly between 0.01% and 99.99%. 割合Δh:hが0.1%と99.9%の間、主として1%と99%の間にあることを特徴とする請求項14に記載の装置(14)。  15. Device (14) according to claim 14, characterized in that the ratio [Delta] h: h is between 0.1% and 99.9%, mainly between 1% and 99%. 割合Δh:hが5%と95%の間、主として10%と90%の間にあることを特徴とする請求項15に記載の装置(14)。  16. Device (14) according to claim 15, characterized in that the ratio [Delta] h: h is between 5% and 95%, mainly between 10% and 90%. 容器(6)が円筒状に形成され、空洞(13)内に同心に配置された雌ねじ(7)を有し、および蓋(8)が前記雌ねじ(7)を補完する雄ねじを含むことを特徴とする請求項1から16のいずれか一項に記載の装置(14)。  The container (6) is formed in a cylindrical shape, has a female screw (7) concentrically disposed in the cavity (13), and the lid (8) includes a male screw that complements the female screw (7). A device (14) according to any one of the preceding claims. 容器(6)が、全容積vが空洞(13)の容積Vより小さい多孔性骨代用材料(1)を含むことを特徴とする請求項1から17のいずれか一項に記載の装置(14)。  Device (14) according to any one of claims 1 to 17, characterized in that the container (6) comprises a porous bone substitute material (1) whose total volume v is smaller than the volume V of the cavity (13). ). 骨代用材料(1)がブロックの形態、主として立方体の、円筒の、中空円筒の、円盤の、くさびの、円錐の、円錐台の、あるいは球の形態であることを特徴とする請求項18に記載の装置(14)。  19. The bone substitute material (1) is in the form of a block, mainly in the form of a cube, cylinder, hollow cylinder, disk, wedge, cone, frustoconical or sphere. The device (14) described. 骨代用材料(1)が、少なくとも部分的にインプラントの表面に連通するようにインプラントに収容されることを特徴とする請求項18または19に記載の装置。  20. A device according to claim 18 or 19, characterized in that the bone substitute material (1) is accommodated in the implant so as to at least partly communicate with the surface of the implant. インプラントが、以下の材料グループのいずれか一グループから選択されることを特徴とする請求項20に記載の装置:
A)金属、および
B)樹脂、および
C)非金属、主としてガラス、および
D)様々な密度の磁器、および
E)複合磁器
またはAからEのいずれか一項。
21. The device of claim 20, wherein the implant is selected from any one of the following groups of materials:
A) Metal, and B) Resin, and C) Nonmetal, primarily glass, and D) Porcelain of various densities, and E) Composite porcelain or any one of A to E.
弾性手段(19)が、中心軸(10)に対称に配置されていることを特徴とする請求項1から21のいずれか一項に記載の装置。  Device according to any one of the preceding claims, characterized in that the elastic means (19) are arranged symmetrically about the central axis (10). 弾性手段(19)が、中心軸(10)に非対称に配置されていることを特徴とする請求項1から21のいずれか一項に記載の装置。  Device according to any one of the preceding claims, characterized in that the elastic means (19) are arranged asymmetrically about the central axis (10). 容器(6)の底(16)が、中心が穿設された、両開口部(4)を形成している接続子(21)を備えていることを特徴とする請求項1から23のいずれか一項に記載の装置。  A bottom (16) of the container (6) is provided with a connector (21) which is perforated in the center and forms both openings (4). A device according to claim 1. 容器(6)の前記底(16)が、非中心が穿設された、前記両開口部(4)を形成している前記接続子(21)を備えていることを特徴とする請求項1から23のいずれか一項に記載の装置。  The bottom (16) of the container (6) is provided with the connector (21) forming the openings (4) perforated in the non-center. 24. The device according to any one of 1 to 23. 蓋(8)の覆板(18)の外側に、中心が穿設された、両開口部(3)を形成している接続子(25)が配置されていることを特徴とする請求項1から25のいずれか一項に記載の装置。  2. A connector (25) having a central opening and forming both openings (3) is arranged outside the cover plate (18) of the lid (8). 26. The apparatus according to any one of 1 to 25. 蓋(8)の前記覆板(18)の外側に、非中心が穿設された、前記両開口部(3)を形成している前記接続子(25)が配置されていることを特徴とする請求項1から25のいずれか一項に記載の装置。  The connector (25) having the two openings (3) formed in the non-center is formed outside the cover plate (18) of the lid (8). 26. An apparatus according to any one of claims 1 to 25.
JP2007513641A 2004-06-03 2004-06-03 Device for impregnation of porous bone substitute material Expired - Fee Related JP4414461B2 (en)

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PCT/CH2004/000335 WO2005118017A1 (en) 2004-06-03 2004-06-03 Device for impregnating a porous bone replacement material

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JP4414461B2 true JP4414461B2 (en) 2010-02-10

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CA2569518C (en) 2013-10-01
CA2569518A1 (en) 2005-12-15
TW200539843A (en) 2005-12-16
WO2005118017A1 (en) 2005-12-15
ATE493158T1 (en) 2011-01-15
KR101161898B1 (en) 2012-07-09
NZ551672A (en) 2010-03-26
DE502004012077D1 (en) 2011-02-10
EP1750781A1 (en) 2007-02-14
AU2004320279A1 (en) 2005-12-15
US8038962B2 (en) 2011-10-18
KR20070018976A (en) 2007-02-14
EP1750781B1 (en) 2010-12-29
TWI363618B (en) 2012-05-11
JP2008501377A (en) 2008-01-24
CN1960770B (en) 2011-08-17
CN1960770A (en) 2007-05-09
US20070221742A1 (en) 2007-09-27

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